Methods for use in surgical gastroplastic procedure

ABSTRACT

Methods and devices are disclosed for performing laparoscopic gastroplasty for the treatment of morbid obesity. The method utilizes a stapling device or clip and a nasogastric tube for positioning the stapling device. A non-absorbable staple support strip or clip is to form and support a passage between a proximal pouch and a distal region in the stomach.

This application is a continuation-in part of application Ser. No.07/939,211 filed Sep. 2, 1992, now allowed.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and devices forsurgically treating obese individuals. More particularly, the presentinvention relates to a method and device for performing gastroplastyprocedures relying on the laparoscopic placement of a vertical bandpartitioning the individual's stomach.

Obesity is the most frequent nutritional disorder in Westerncivilization. In the U.S., over 34 million citizens between the ages of20-75 are overweight, and of those, 12.4 million are morbidly obese,i.e. being 100 pounds over their desirable weight or having one or moreserious medical conditions in association with obesity. Such morbidobesity carries with it a greatly enhanced risk of premature death,particularly between the ages of 25-35, where there is a 12-foldincreased risk of death compared with the non-obese. The most commoncauses of death are heart disease, stroke, diabetes mellitus, cancer,pulmonary diseases, and accidents.

Presently there are but two methods of treatment for morbidobesity--diet and surgery. Numerous studies have found diet alone isgenerally unsuccessful with recidivism rates approaching 95%. Afterabandoning the highly successful jejunal-ileal bypass surgical procedureperformed in the early 70's because of its unacceptably high rate oflate metabolic complications, surgeons have developed two differentgastric surgical approaches--the Vertical Banded Gastroplasty (hereaftercalled VBG) and the Gastric Bypass. Each of these procedures has itsadvantages and disadvantages- The Gastric Bypass, which entails shortcircuiting the gastric pouch, has previously been more successful inbringing about sustained weight loss. However, the procedure is moredifficult to perform, has a higher rate of catastrophic post-operativecomplications, and produces long term deleterious changes due to thererouting of the alimentary flow.

Vertical Banded Gastroplasty is more commonly performed than GastricBypass because it is simpler, has fewer major complications, and doesnot disturb normal alimentary continuity. VBG relies on stapling thestomach to create a small partitioned pouch high up in the stomach thatcan contain no more than 50 ml of food and liquid, where the pouch has asmall diameter (typically not exceeding 10.7 mm) controllednon-dilatable outlet to the larger stomach. The smaller pouch whichreceives food and liquid directly from the esophagus (gullet) will fillquickly. Because the outlet from this smaller pouch into the largerstomach is quite narrow, the patient will experience early satiety,which in turn will decrease the appetite and result in weight loss.

Vertical Banded Gastroplasty is accomplished by accessing the patient'sgeneral peritoneal cavity through a very long abdominal incision and anexemplary procedure involves the following steps.

Step 1: The lesser curvature of the stomach is dissected from anyattaching structures over a distance of about 3 or 4 cm. This requiresclearing all blood vessels and nerves from the anterior and posterioraspects of the stomach.

Step 2: A 32 French Ewald rubber tube is placed through the patient'smouth and into the stomach and is held against the lesser curvature(32f=10.7 mm, this tube calibrates the size of the outlet). A specialstapling device called an EEA™ (U.S. Surgical Corporation, Norwalk,Conn.) punctures both gastric walls, then punches-out and seals a 28 mmdiameter circle in both walls of the stomach. Thus, a small hole iscreated in the stomach by stapling the front and back walls of thestomach together.

Step 3: A second stapling device (TA-90B™, available from U.S. SurgicalCorporation, Norwalk, Conn.) is specially designed to place 4 rows oflinear staples and is introduced through the stomach hole so that thelower jaw of the staple device is on the back wall of the stomach andthe upper jaw of the staple device is on the front wall of the stomach.The length of stomach that needs to be stapled varies from 5-9 cm. TheTA-90B™ stapling device is then placed so that its longitudinal axis isparallel to a line from the opening of the esophagus to the new outletopening constructed next to the punched-out hole. After measuring theproposed volume of the partitioned pouch and making it somewhere between15 ml and 50 ml, staples in a double row are then fired through bothwalls of the stomach.

The stomach is now compartmentalized into a smaller proximal pouch whichcan accommodate only small portions of food. To gain access to the muchlarger portion of the stomach and the remainder of the digestive tract,food must pass through the narrow exit opening which is the new outletfrom the smaller proximal portion of the stomach.

Step 4: The new outlet is encircled with a band of polypropylenenon-absorbable mesh which measures 5.5 cm×1.5 cm (the mesh resembles ascreen door). This band encircling the newly constructed outlet willform a collar. The mesh is placed through the punched-out hole and issecured around the outer surface of the outlet. The mesh, once suturedto itself, prevents the inner diameter of the outlet of the stomach fromstretching beyond is initial diameter.

Thus, the steps of the VBG procedure compartmentalize the stomach into alarger portion and a smaller portion. The smaller portion is verticallystapled and its outlet banded with a piece of non-absorbable mesh toinsure that it will not increase in size. The smaller pouch will hold avolume of 15-50 ml, and the exit opening, by virtue of its being banded,will not increase in diameter. Such features serve to insure that thepatient who attempts to eat too much, too fast will have early satietyand not overeat.

While this procedure has been successful, it suffers from the fact thatobese patients are poor surgical risks. The surgery requires a very longincision, extending through an extremely thick layer of fat.Post-operative healing of such incisions is highly problematic. Theprocedure is difficult for the surgeon to perform because of the poorexposure associated with the enormous size of these patients.

With the exception of a few centers, VBG has fallen into disuse becauseof the difficulties associated with the performance of the procedure andthe high rate of complications that ensue afterwards. Earlycomplications, such as wound infection, pulmonary emboli, gastricperforation, and subphrenic abscess, are serious and the early mortalityfigure in the best series runs between 1-3%. Many early complicationsnecessitate reoperation.

Late compilations, such as ventral (incisional) hernias and gallbladderstones, also occur. The most troubling late complication is a disruptionof the vertical linear rows of staples. When this occurs, the smallerpartitioned stomach now has two openings into the larger stomach and thebenefits of the procedure are immediately negated.

In recent years, less invasive surgical (LIS) techniques, such aslaparoscopic, thoracoscopic, and arthroscopic techniques, have beenperformed through small incisions. Such LIS procedures use specializedinstruments to carry out the desired surgical result. For abdominalsurgery, the specialized instruments are usually introduced through atube, such as a trocar, while the surgeon observes the manipulation ofthe instruments through a laparoscope. The image is transmitted by meansof a camera attached to the laparoscope to a visual monitor. LIStechniques offer significant advantages over conventional "open"surgical procedures. In particular, the LIS techniques are generallymuch less traumatic, require substantially shorter recovery periods, andare less costly than corresponding, conventional surgical techniquessuch as open abdominal surgery.

Accordingly, it would be desirable to provide methods and devices forlaparoscopically performing gastroplasty procedures. Such laparoscopicgastroplasty procedures would lessen or avoid the morbidity associatedwith open surgical gastroplasty procedures. Further, it would beadvantageous to perform gastroplasty procedures in a manner that reducedthe possibility of staple disruption.

2. Description of Background Art

Surgical gastroplasty procedures are described in Mason (1982) Arch.Surg. 117:701-706; Willibanks (1986) Surg. 101:606-610; and Deitel et.al. (1986) 29:322-324. Willibanks (1986) illustrates the TA-90™ surgicalstapling device manufactured by U.S. Surgical Corporation, as describedabove. A gastroplasty method employing a specialized clamp having anaperture to define the small diameter flow passage between thepartitioned portions of the stomach is described in U.S. Pat. No.4,803,985. A laparoscopic stapling device is described in U.S. Pat. No.5,040,715, the full disclosure of which is incorporated herein byreference. U.S. Pat. No. 4,802,614 discloses a surgical stapling devicewith features similar to the model TA-90™ manufactured by U.S. SurgicalCorporation.

SUMMARY OF THE INVENTION

The present invention relates to a method for performing laparoscopicsurgical gastroplasty and devices for use in such procedures. Whensurgery is performed in this manner, the morbidity associated with anopen procedure is reduced or avoided.

A method and related apparatus for performing laparoscopic gastroplastyon a patient includes percutaneously introducing a plurality of trocarsthrough the patient's abdominal wall in place of an abdomen openingincision. Visualization of the patient's stomach using a laparoscopedisposed in one of the trocars is utilized. The stomach is surgicallyprepared and manipulated to expose the walls of the stomach forplacement of a band which will partition the stomach into twocompartments with an opening between them. Specifically the stomach isdissected from the surrounding mesentery along a line dividing thestomach into a proximal pouch adjacent the esophagus and a distalregion. A banding device is introduced and positioned to bring the wallsof the stomach adjacent to one another between the proximal pouch andthe distal region of the stomach. The banding device defines an aperturefor permitting flow from the proximal pouch to the distal pouch. Anasogastric tube is introduced into the stomach so that it passesthrough the aperture in the band device. A first balloon is inflated onthe nasogastric tube distally of the aperture to close the proximalpouch. A second balloon is inflated in the esophagus, causing theproximal pouch in the stomach to be sealed. A measured volume of fluidis injected through the naso-gastric port into the proximal pouchthrough the nasogastric tube until the pouch is filled and the pouchsized. The banding device is repositioned until the position of thebanding device provides a preselected fluid volume to the operativedefined pouch upon filling. Thereafter, the banding device is radiallyfastened around the stomach with sufficient force to bring the opposingwalls of the stomach together to divide the proximal pouch from theanterior portion of the stomach. The banding device is thereafterstapled at least to the superficial walls of the stomach or otherwisefastened to the stomach to prevent migration. The banding device at itsfinal position, produces a proximal pouch with diminished volume toproduce early patient satiation upon eating for surgically inducedobesity control with a passage between the proximal pouch and distalregion of the stomach being defined by the aperture for nutrients.

The present invention overcomes many of the disadvantages ofobesity-related surgery discussed above. Laparoscopy is utilizednegating abdomen opening incision.

Two types of banding devices and related surgical procedures are setforth. The first banding device is a strip for providing the apertureand stapling the walls of the stomach one to another. The second bandingdevice is a clamp having opposed portions for bringing the walls of thestomach in sealing contact with one another and defining the requiredaperture.

In the stapled band embodiment, a laparoscopic stapling device isprovided which in a single step can effect both (1) vertical staplingpartition of a stomach and (2) banding of the stomal outlet. Byemploying a non-absorbable tissue supporting material beneath thestaples, surgical failures associated with disruption of the staple linewill be decreased.

Two specialized devices are employed in the stapled banding device andrelated surgical method of the present invention. First, a laparoscopicstapling device provides a means for applying a substantially lineararray of staples. The stapler includes a fastening head comprising ahousing, or upper jaw, that has a means for mounting surgical staples.The staples will be stored in, and subsequently ejected from, thehousing. The housing provides for firing of the staples from a regionsubstantially at the distal end of the housing, to a position spaceddistally from the proximal end of the housing. The fastening head alsoincludes an anvil, or lower jaw, that defines a surgical staple guidingsurface. The anvil is pivotally mounted relative to the housing so thatthe anvil and housing can move between an open and a closed position.The closed position will further include a cocked position and a fireposition, as described in more detail below. The fastening head willhave a tissue contacting surface that extends along the housing andanvil. When the anvil and housing are in the open position, sufficientspace is provided to allow positioning of the anvil and housing onopposite sides of a human stomach. When the anvil and housing are in aclosed position, they define an aperture near their respective proximalends, in the region where staples are not fired. The aperture defined bythe anvil and housing will generally have a longitudinal axis orientedfrom between 20° to 50° relative to the longitudinal axis of thefastening head, with a diameter selected to provide a desiredcross-sectional area for the outlet passage between the divided portionsof the stomach, as discussed below.

The housing and anvil of the fastening head will typically carry a thinnon-absorbable support strip that covers the tissue contacting surface.This non-absorbable support strip is preferably a continuous length ofmesh material which defines the non-absorbable tissue supportingmaterial between the staples and the tissue after the staples have beensecured in the stomach wall.

Second, a nasogastric tubular device having proximal and distal endscomprises an access port, a first tubular portion, a first balloon, asecond tubular portion, and a second balloon located substantially nearthe distal end of the device. The second tubular portion of the devicemay have an emission port. Separate lumens can connect the distalballoon, the emission port, and the proximal balloon to the access portat the proximal end of the device.

The stapled banding procedure of the present invention is carried-outlaparoscopically, although the devices might also find use inconventional open-surgical methods. Accordingly, the method of thepresent invention comprises laparoscopically accessing the stomach andthen stapling the stomach in a manner which forms the stomach intoproximal and distal chambers having a reduced-size passage therebetween.After the stomach is accessed, it is manipulated to facilitate placementof the staple device along a generally desired dividing line.Thereafter, the nasogastric tube of the present invention is introducedthrough the mouth and throat to help in accurately positioning thestapling device to provide the desired capacity of the proximal stomachchamber. The stapling device is cocked to the compressed walls of thestomach, with the second tubular portion of the nasogastric tube passingthrough the region of the stomach located within the aperture of thestapling device. The emission port of the second tubular portion islocated proximal to the aperture, and the distal balloon of the tube islocated on the distal side of the stapling device. The proximal anddistal balloon of the tube are inflated with the proximal balloonoccluding the distal end of the esophagus. A quantity of solution isintroduced to the tube and flows into the proximal portion (pouch) ofthe stomach via the emission port. Preferably, the amount of fluidintroduced will be approximately 15-50 mm (the desired final volume ofthe proximal pouch of the stomach after stapling). Thereafter, thestapling device will be fired to position and close a line of staples(engaging both the front and back of the support strip described above)to form the proximal stomach chamber having the desired capacity.

In the clamp device and procedure, an especially designed clamp isutilized for enabling trocar introduction, laparoscopic banding of thestomach, and conventional stapling which is not through and throughstapling. The function of these staples is to prevent migration of theclamp. The clamp includes posterior and anterior portions connected atone end by a hinge and at the opposite end by a fastening device,preferably screw and wing nut attached to the posterior portion forfastening and threading to a receiving opening in the anterior portion.Medially of both the anterior portion and posterior portion, the stomachcontacting clamp sides are interrupted and have fastened at their pointof interruption elastic arches spanning the interruption. These elasticarches define the required stomach aperture and have a flexible arcuatestrip underlying the elastic arches to permit formation of theunderlying aperture once the clamp is applied to the stomach. Theelastic arches also impart sufficient flexibility to the posterior andanterior clamp sides for trocar introduction. Both clamp sides areprovided with windows for exposing the underlying stomach wall betweenthe top and bottom portions of the clamp. These windows allow state ofthe art pulse oximeter monitoring or Doppler blood flow of the stomachwalls to remotely measure arterial blood flow during clamp installationfor precision tightening of the clamp during installation. Finally, theanterior portion of the clamp includes woven mesh material extendingabove and below the clamp which enables superficial stapling of theclamp in place against unwanted migration.

A method for performing laparoscopic gastroplasty on a patient utilizingthe clamp device includes percutaneously introducing a plurality oftrocars through the patient's abdominal wall in place of an abdomenopening incision. As before, visualization of the patient's stomachusing a laparoscope disposed in one of the trocars is utilized. Againand as before, the stomach is dissected from its mesentery along a linedividing the stomach into a proximal pouch adjacent the esophagus and adistal region. A pliable catheter is threaded in an entrance trocar,around the posterior portion of the stomach and threaded out an exittrocar. At the exit trocar, the clamp--preferably in the closedposition--is fastened typically at the wing nut of the posteriorportion. Thereafter, the clamp is drawn by the tube until the posteriorportion is behind the stomach. Once the posterior portion of the clampis in place behind the stomach, the anterior portion is folded over thestomach to close the clamp with the wing nut and notch holding the clampgenerally closed for defining the proximal pouch. As before, thenasogastric tubular device is utilized to size the pouch and manipulatethe clamp to define the required size proximal pouch. Once the correctsize of pouch is determined, the clamp is closed and tightened utilizinga pulse oximeter or Doppler device to measure stomach wall arterialblood flow to gauge correct clamp tightness. Finally, stapling of theanterior clamp portion attached mesh to the anterior portion of thestomach occurs. This latter procedure assures that migration of theclamp does not occur.

At least three distinctions over similar clamp type devices andprocedures found in the prior art are present. First, this applicationis for laparoscopic insertion (although it could be used just as well inan open procedure). Secondly, by stapling the mesh coming off the topand bottom portions of the anterior jaw of the clip provide a means toprevent the disclosed clip from migrating; the prior art does notdisclose a mechanism to prevent this from occurring. Finally, by using asensing device to determine blood flow, my invention would preventtissue necrosis. The disclosed screw-thread clasp in combination withthe windows for arterial blood monitoring will give the surgeon theability to adjust the tightness of the clip while at the same timemeasuring blood flow to make sure the gastric wall is being nourished.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side, elevation view of a laparoscopic stapling deviceemploying the specialized fastening head of the present invention.

FIG. 2 illustrates the tissue-contacting surface of the staple housingof the fastening head of the stapling device of FIG. 1.

FIG. 3 illustrates the tissue-contacting surface of the anvil of thefastening head of the surgical stapling device of FIG. 1.

FIG. 4 is a detailed side view of the fastening head of the surgicalstapling device of FIG. 1, with portions broken away, shown in its open,tissue-receiving configuration.

FIG. 5 is a detailed view of the fastening head of the surgical staplingdevice of FIG. 1, similar to FIG. 4, except that the housing and anvilare closed together in the stapling configuration.

FIG. 6 illustrates the nasogastric tube of the present invention, withits first and second balloons deflated.

FIG. 7 illustrates the nasogastric tube of FIG. 6, with its first andsecond balloons inflated.

FIGS. 8-12 and 14 illustrate the stomach of an individual undergoing alaparoscopic gastroplasty procedure according to the method of thepresent invention.

FIG. 13 illustrates the fastening head of the surgical stapling devicewith a portion of the patient's stomach wall therein, with the passagebetween the distal and proximal divided portions of the stomach beingillustrated.

FIG. 15 is a cross-sectional view of the portion of stomach which hasbeen stapled according to the method of the present invention using thestapling device of the present invention, with a plurality of individualstaples and strip of tissue supporting material in place.

FIGS. 16A-16D are respective anterior, posterior, proximal, and distalviews of the closed clamp utilized in the clamp banding procedure ofthis invention.

FIG. 17 is a posterior perspective view of the clamp shown in the closedposition illustrating the opposed posterior and anterior portions of theclamp closed with the elastic arch portions medially of the clamp andthe underlying woven mesh at the arch portions defining the requiredaperture of the stomach.

FIG. 18 is an anterior view of a patient's stomach illustratinglocations of trocars for the clamp insertion procedure of thisinvention.

FIG. 19 is a schematic section of the stomach with an inserted Endo-Handand illustrating on either side of the stomach the path around which thetube is inserted.

FIGS. 20 and 21 are schematics illustrating the tube drawing the clampof this invention, posterior portion first, around the posterior portionof the patient's stomach.

FIGS. 22 and 23 are schematics illustrating the closure of the anteriorportion of the clamp over the stomach to roughly size the proximalpouch.

FIGS. 24 and 25 are details illustrating the attachment of the wing nutto the tube to enable the procedure of FIGS. 20 and 21.

FIGS. 26 and 27 illustrates detachment of the wing nut from the tube bycutting of sutures connecting the tube and wing nut.

FIGS. 28 and 29 illustrate closure of the clamp.

FIGS. 30 and 31 illustrate positioning of the clamp to define therequired section of proximal pouch.

FIGS. 32-34 illustrate tightening of the clamp with arterial pulsemeasurement at the stomach wall to assure proper clamp tightening.

FIG. 35 illustrates stapling of the mesh on the anterior portion of theclamp to the anterior exposed portion of the stomach to preventmigration of the clamp.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

According to the method of the present invention, a gastroplastyprocedure is performed laparoscopically. Two specialized instruments areutilized that facilitate laparoscopic gastroplasty. However, thesedevices can be used in an open surgical procedure as well.

The first specialized device is a stapling device 10 (FIGS. 1-5) whichincludes an endoscopic tube 12 having a proximal end 14 and a distal end16. A handle 18 is rotatably attached to the proximal end 14 of theendoscopic tube 12 and includes a cocking lever 20 and a firing trigger22. A locking latch 24 is further provided in order to preventaccidental firing of the staples, as will be described in more detailhereinafter.

The stapling device 10 further includes a fastening head 30 at itsdistal end, with the fastening head including a housing 32 (upper jaw)which carries a plurality of rows of staples and an anvil 34 (lower jaw)which acts to close the staples after they are ejected from the housingusing the trigger 22. The cocking handle 20 may be moved up and down inorder to open and close the anvil 34 against the housing 32.

As thus far described, the stapling device 10 is constructed and willeffect stapling in the manner of the commercially available laparoscopicEndo-GIA™ stapling device, available from U.S. Surgical Corp., Norwalk,Conn. The stapling device 10 of the present invention, however, must bemodified to include features not present in previous stapling devices.

In particular, the fastening head 30 of the stapling device 10 of thepresent invention must include a specialized housing 32 and aspecialized anvil 34, as best illustrated in FIGS. 2-5. The housing 32and anvil 34 will each be sufficiently long to staple the desiredpartition in the stomach, usually being approximately 8 cm to 12 cm inlength, preferably being about 9 cm in length. The housing 32 has astaple storing region 36, and a depression 38 that lacks staples. Theanvil 34 has staple guiding surfaces 40, and a depression 42 which willalign with depression 38 in housing 32 to form an aperture 44 (FIGS. 4and 5), which defines the passage between the partitioned portions ofthe stomach, as described hereafter. The staple guiding surface 40 causeB-shaped bending of the staples when the fastening head 30 of the device10 is closed and fired.

Of particular importance to the present invention a staple support strip50 (FIGS. 1, 4, and 5) will be carried along the inner,tissue-contacting surfaces 52 of both the housing 32 and anvil 34, aswell as over the surfaces of the depressions 38 and 42. The strip 50 isformed continuously so that when the anvil 34 is closed against thehousing 32, and the staples S are fired, the staples will firmly attachthe adjacent portions of the staple support strip 50 together, as wellas any tissue which may have been between the opposed portions of thesupport strip when the staples were fired. As the depressions 38 and 42are free from staples, however, the support strip 50 will maintain anenlarged passage through the region which was located in the depressionsat the time of firing.

The tissue support strip 50 may be any biologically compatible materialhaving sufficient strength to act as backing for the staples S and todefine a fixed aperture diameter for the connecting region between theproximal and distal portions of the stomach, as described in more detailhereinafter. A preferred tissue support strip material is a polymericmesh, with a particularly preferred material being Marlex™, availablefrom Ethicon Corporation, New Brunswick, N.J.

When open (FIGS. 1 and 4), the fastening head 30 defines an open region60 that is sufficient in size so that the housing 32 and anvil 34 can bepositioned on opposite sides of a human stomach. When the fastening head30 of the stapling device 10 is closed (FIG. 5), the housing depression38 and anvil depression 42 define the aperture 44, which leaves the onlypassage between the proximal and distal portions of the stomach afterstapling. Preferably the aperture will be ovoid in cross section. Thepreferred oval shape of the aperture allows the stapling device to havea smaller overall diameter. The aperture 44 will be oriented at an acuteangle of between 20° and 50°, and most preferably is approximately 30°relative to the longitudinal axis of the fastening head 31. The angle ofaperture 44 is necessary in order to properly orient the passage betweenthe proximal and the distal portions of a patient's stomach when thefastening head 30 is introduced from a typical laparoscopic accessdirection. That is, it will be difficult or impossible to orient thestapling device 10 itself in order to achieve the desired angle, so theangle is preset into the fastening head to facilitate use.

The device 10 of the present invention will typically be longer thanconventional laparoscopic stapling devices of the prior art, toaccommodate the increased girth of the patients. Preferably, the deviceis at least 50 cm in length often being longer. Preferably, the devicewill also have an articulated fastening head allowing up to 30° or moreof lateral deflection.

The second specialized device utilized in the surgical gastroplastymethods of the present invention is a nasogastric tube 70, asillustrated in FIGS. 6 and 7. The tube is used in conjunction with thestapling device 10 of the present invention in order to properlyposition the line of staples which is being discharged by the stapler.This tube 70 will be constructed of materials, and by methods known tothose in the art, typically being formed by the extrusion of polymericmaterials, such as polyethylene, PET, PVC, and the like.

The nasogastric tube 70 includes flexible tube body 72 having a proximalend 74 and a distal end 76. The main portion of body 72 will have anouter diameter in the range from about 6 to 9 mm, preferably being fromabout 6 to 9 mm, although the diameter is not critical. A first, distalballoon 80 is formed near the distal end of body 72 and is connected toinflation lumen 82 at the proximal end of tube 70. A second, proximalballoon 84 is located proximally of the distal balloon, typically beingspaced from the distal balloon by a distance in the range from about 6cm to 10 cm, usually from about 6 cm to 10 cm. The proximal balloon 84is inflatable through lumen 86 located at the proximal end of the tube70. An emission port 90 is formed in the body 72 and disposed betweenthe balloons 80 and 84, preferably lying just distally of the proximalballoon 84. Emission port 90 is connected to lumen 92 at the proximalend of the tube 70, allowing the user to introduce a fluid into a regiondefined between the inflated balloons 80 and 84, as illustrated in FIGS.7 and 12.

The diameter of tube 70 between the balloons 80 and 84 will be selectedto help define the diameter of the passage which is being createdbetween the proximal pouch and distal region of the stomach. Typically,the diameter will be between 6 mm and 15 mm, more usually between 6 mmand 9 mm, and most usually being about 6 mm.

Preferably, the steps involved in laparoscopically performing thisoperation, utilizing the newly described devices, are as follows.

Step 1: The patient is prepared for surgery in the usual manner. A footboard is placed to allow the patient to be placed in a head up position.

Step 2: After the patient is anesthetized, and pneumoperitoneum isobtained in the standard fashion, trocars are placed as they would befor any laparoscopic gastric procedure, with a 15 mm port usually beingnecessary for the introduction of the stapling device 10. Typically,four trocars are needed: A right lateral upper quadrant trocar for liverretraction, a 10 mm umbilical port for a 0 to 45 degree straightlaparoscope, a 15 mm operating port in the right upper quadrant, and a10 mm port in left upper quadrant.

Step 3: The surgeon next manipulates the stomach so as to visualize thevessels on the stomach wall. Preferably, a intragastric manipulatingdevice will be used, where the device is introduced orally andmanipulated from its proximal end. The manipulating device willtypically include means for attaching to tissue located at its distalend. The means for attaching to tissue usually includes a vacuumattachment head which may be reciprocally positionable within and out ofa lumen at the distal end of the device.

Manipulating movements achievable by the intragastric manipulatinginclude the ability to deflect the distal end of the device up to about270° from the longitudinal axis; the ability to move the device up toabout 45° from the longitudinal axis at a location intermediate of theproximal and distal ends of the device; and the ability to move thedevice up to about 180° rotatably, relative to the longitudinal axis ofthe device, the rotatable movement occurring at a location intermediateof the proximal and distal device ends.

By use of such a intragastric manipulating device, the surgeon mayeffectively manipulate the stomach from the inside instead of bygrasping and retracting the stomach from the outside in order tovisualize vessels on its wall and to carry out vaso-occlusion.

Step 4: With the stomach retracted laterally, the vessels of the lessercurvature are stretched. Using a microscissor (Endoshears™; USSCNorwalk, Conn.), the peritoneum is incised along the lesser curvature ofthe stomach for a distance of 2-3 cm. This dissection is performed at asite approximately 4-5 cm distal to the incisura (the junction betweenthe lateral side of the esophagus and the stomach and just above thecrow's feet of the Nerve of Latarjet). See FIGS. 8 and 9. Vaso-occlusionafter ligation of the vessels on the stomach wall is accomplished withknot tying, and clipping. During vessel ligation, care is taken to notdisturb the anterior nerve of Latarjet.

Step 5: The stomach is then rotated to bring the posterior wall of thelesser curvature into view, allowing the surgeon to continue theligation and clipping of the vessels that enter on the posterior wall ofthe lesser curvature. Accordingly, a passage will be created along thelesser curvature and along the posterior wall of the stomach.Preferably, the intragastric manipulating device used in Step 3, will beutilized to facilitate stomach manipulation and vaso-occlusion.

Step 6: An flexible endoscope, such as that commercially available fromOlympus (Olympus Corporation, Lake Success, N.Y.) is then gentlyinserted through the 15 mm trocar and insinuated along the posteriorwall of the stomach, through the passage being created between thedivided blood vessels of the lesser curvature. Endoscopic visualizationpermits the surgeon to determine if any vessels have not been ligated.Should further ligation be necessary, the process of ligation andvaso-occlusion as set forth in Step 5 is continued. Preferably, themanipulating device described in Step 3 is positioned within the stomachand used to elevate the stomach toward the anterior abdominal wall whilethe endoscope is being inserted. Should the stomach be manipulated withsuch an intragastric device, the lesser sac behind the stomach isexposed, while also stretching the peritoneal reflection as well as anyaberrant posterior gastric blood vessels.

Preferably, the endoscope is advanced using flexible dissectinginstruments to clear a path. Any vascular adhesions or non-dissectedperitoneum would preferably be cut using the flexible scissors.Adhesions containing small blood vessels would be grasped and cauterizedutilizing methods and devices known to those of skill in the art. If asignificant blood vessel should be encountered, a flexible clip applierwould preferably be introduced and clips placed on the vessel bothproximally and distally. A flexible scissor would then be introduced andused to divide the vessel between the clips. In the event thattroublesome bleeding should occur in this relatively inaccessible area,injection of fibrin glue should control the bleeding. As is known in theart, pre-operative preparation would have included the preparation offibrin glue made from the patient's own blood products.

The flexible endoscope is advanced into the free space behind thestomach until it emerges at the incisura (the junction between thelateral side of the esophagus and the stomach). The light from theendoscope is visualized during this maneuver by means of the laparoscopethat is in place through the umbilicus. (Solos Corp., Atlanta, Ga.).

When the flexible endoscope arrives at the upper end of the space behindthe stomach, it will be seen through the peritoneum that attaches thestomach to the diaphragm. This peritoneal veil could be broken throughfrom below, using the flexible endoscope. Alternatively, dissection ofthis peritoneal veil could be carried out from above by observing withthe laparoscope and clearing away any blood vessels and tissue veils inthis relatively avascular plane, utilizing procedures and methods knownto those of skill in the art. Thus, a passage is created along theposterior wall of the stomach on the lesser curvature side whileinsuring that disadvantageous bleeding does not occur.

Step 7: The stapling device 10 (FIGS. 10-12) is then introduced througha trocar, and the anvil 34 of the instrument is placed into the tunnel(shown in broken line in FIG. 9) created behind the stomach guided by arubber tubing previously placed in the tunnel and attached to thehousing of the stapling device.

Step 8: Once the anvil 34 of the stapling device 10 is visualizedemerging from the gastro-esophageal junction, the surgeon closes thefastening head 30 of the stapling device (FIG. 10), thereby compressingthe anterior and posterior walls of the stomach. The specializednasogastric tube 70 is then inserted into the stomach and observed topass through the stomach opening delimited by the aperture of thestapling device (aligned beneath the esophagus). See FIGS. 11 and 12.The tube 70 is passed into the distal region of the stomach under directvision with the laparoscope. It will be seen as a protrusion proceedingalong the stomach wall. A portion of the stomach compressed within theaperture 40 of the stapling device 10 and around the distal portion ofthe nasogastric tube, will be the future outlet of the partitionedstomach. When the nasogastric tube 70 is positioned within the staplingdevice 10, the typically round outer shape of the second tubular portionwould be flattened into an oval, conforming with the preferred shape ofthe aperture of the stapling device.

Step 9: The distal balloon 80 of the tube 70 is inflated, and thesurgeon pulls this balloon proximally thereby cinching the balloonagainst the opening delimited by the aperture 40 of the stapling device10. Cinching the balloon 80 in this manner prevents loss of fluid fromthe proximal portion P of the stomach.

Step 10: The proximal balloon 84 is then inflated, and its position inthe esophagus observed under direct vision with the laparoscope. SeeFIG. 12.

Step 11: The proximal chamber P of the stomach is then filled with ameasured amount of saline solution. Preferably, the proximal chamber ofthe stomach will hold between 15-50 ml of solution. The stomach isusually filled by introducing fluid into the lumen 92 of the nasogastrictube 70 that leads to the emission port 90 located proximate the balloon84. In the event that the proximal portion of the stomach is too largeor too small, the surgeon can open the fastening head 30 of the staplingdevice 10 and reposition the head, repeating the procedure of this Stepuntil satisfied with the size of the proposed proximal gastric pouch P.

Step 12: The safety release 24 is taken off the stapling device 10, andthe device then fired. As is known to those skilled in the art, thiswould activate pusher bars to eject multiple rows of staples from thehousing 32 of the instrument. These staples would emerge from thehousing, pass through the support strip 50, pass through the anteriorwall AW of the stomach, pass through the posterior wall PW of thestomach, through the support strip on the anvil 34 of the staplingdevice, then striking the posterior jaw or anvil 34 of the device. Uponstriking the anvil 34, the staples S would form into a B shape, lockingand making a sandwich of the anterior mesh portion, the anterior andposterior stomach walls, and the posterior mesh portion, as illustratedin FIGS. 14 and 15.

Since the distal end of both jaws of stapling device will preferablyextend beyond the stomach of the esophagogastric junction, the staplesat the distal-most end of the stapling device will not engage thestomach. These staples would fire through the two layers of mesh only,forming a fastened tail 100 which serves to ensure that disruption ofthe staple line at this edge will not occur.

When the stapling device 10 has been fired, and the stapling device andnasogastric tube 70 removed, the flattened oval portion of the stomachformerly located between the stapling device and the tube and compressedinto an oval shape will regain its circular shape, preferably having theoptimum 10.7 mm outlet configuration (102 in FIG. 15) and will be bandedby the mesh 50 that lined the stapling device 10.

Step 13: The surgeon withdraws the stapling device 10, and afterirrigation removes the instruments and trocars, and closes the skinincisions in a standard fashion. Postoperative care can be simplified byleaving the double lumen tube in place overnight to lessen complicationsattendant to swelling and bleeding. Ideally, the patient will be senthome the following morning on a clear liquid diet.

FIGS. 16A through 35 illustrate the second embodiment of banding thestomach utilizing a clamp type device 100. The concept is to band thestomach externally with a clip dividing it into two chambers. Referringto FIGS. 16A-16D and 17, the clip 100 is placed horizontally high acrossthe fundus of the stomach. The inlet chamber or proximal pouch will berestricted to 30-50 cc of capacity. Through the center of the rigid clipthere is a controlled opening 102 that allows food to pass between thetwo chambers. This opening is banded with biologically insertnon-absorbable mesh 104, 105 to prevent stretching and the diameter ofthe mesh permanently regulates the size of the outlet preventing it fromenlarging. Arches of semi-rigid plastic 108, 109 over the openingmaintain the integrity of the clip's design.

Such a clip 100 accomplishes the two goals of the vertical bandedgastroplasty operation: a small ante chamber and a controlled outlet. Byproviding external support instead of relying on through and throughstaples, clip 100 avoids staple line breakdown which has been theprinciple reason this operation has fallen into disrepute.

As will hereinafter be more fully set forth with respect to FIGS. 18through 35, clip 100 is inserted down a trocar, preferably in the closedposition. Once in the abdomen, the posterior jaw of the clip is guidedinto place by affixing its leading edge to a soft rubber tube alreadythreaded behind the stomach. Once the clip is in place it is fastened bymeans of a screw through its clasp. The surgeon is in control of thetension applied to the stomach.

The requirements for clip 100 are the following:

1) It must be rigid enough to compress the two walls of the stomach toprevent leakage of food or fluid across the barrier created by the clip.

2) It must not be so tight as to cause necrosis of the stomach wallwhich could lead to ischemia and then perforation.

3) It must be coated with a biologically inert substance that wouldlessen the possibility of erosion into the stomach.

4) It must be additionally fastened to the stomach wall without the useof through and through staples so as to ensure against possiblemigration of the clip.

5) It must have a surface that will not encourage adhesions tosurrounding organs.

6) The opening in the clip allowing food to pass from one chamber toanother must be controlled.

Detailed construction of the clip 100 can be understood with respect toFIGS. 16A-16D, and 17. Its key features include:

1) 9-12 cm in length and one cm added for the clasp.

2) 10-12 mm in width.

3) 12-15 mm in depth when closed for passage down a 12 or 15 mm trocar.

4) The clip should have rounded edges so that it fits down a circulartrocar--See FIGS. 16C and 16D and FIG. 17.

5) A hinge 120 is required for the side that will be placed on thelesser curvature side of the stomach.

6) Frames 130 consisting of flexible yet fairly rigid plastic for bothsides of the clip.

7) Arches 108, 109 bridge the frame in the middle leaving an ovalopening on both sides of the clip. This arch should also be of flexibleplastic that is fairly rigid. This enables clip 100 to straighten whenpassed down a trocar, but will spring back into its arch shape uponarriving inside the peritoneal cavity.

8) Attached to the frame of each jaw of the clip in the middle aresegments of woven mesh 104, 105. This mesh bridges the gap between thetwo straight segments 130 of the jaws and lies directly under theplastic arches 108, 109 that provide rigidity to the whole clip. Thearches of plastic 108, 109 connecting the two straight elements 130 ofthe frame on either side of this opening 102 accommodate the mesh 104,105 when it is fully expanded.

9) Covering each jaw on both inner and outer sides will be a thin pieceof solid Gore-tex™. The struts of the arch will also be covered withGore-tex™. This material prevents adhesion of the clamp 100 to adjacentorgans.

10) The posterior jaw has a protruding thread screw 140 with a wing nut142 attached to it. Its design allows the fastening of a rubber tube.The tube can be removed intraperitoneally without difficulty.

13) This protruding thread screw 140 is on a hinge 144. Once the rubbertube is removed, it can be flipped up using a standard grasper to lie 90degrees to the plane of the jaw.

14) The anterior clamp has a clasp 150 on the end of it to receive thisupright screw through an opening of clasp 150. The clasp 150 at itscorners should be rounded so as to not present any sharp edges to thepatient's tissue.

15) There are slots 160 in the middle of the anterior jaw 2 mm widerunning the length of the device. A linear segment of the anteriorstomach wall that is clamped in the clip will be exposed through thisslot along its entire length except for where the mesh for the openingbetween chambers resides. This slot can be used to assess the blood flowin the crushed segment of the stomach wall.

11) Attached to the superior and inferior aspects of the anterior jawand extending beyond for a distance of one cm are four segments of wovenmesh material 170 such as Marlex™. Affixing these segments of mesh tothe anterior gastric wall by means of a standard laparoscopic staplingdevice such as is used in hernia repairs will prevent the clip 100 frommigrating.

Having described the overall construction of the clip, the procedure inwhich the clip is utilized may now be described.

1) The patient is anaesthetized and placed supine on the operating tablein a slightly head up position.

2) Ports 200-203 are placed in the positions indicated and arerespectively for optic fiber (200), 12 mm trocar 201, and 10 mm trocars202 and 203.

3) Endo-Hand 205 is inserted into the patient's stomach S and a 2-3 cmsection high on the lesser curvature is cleared away from its mesenteryat 210. The nerves of Laterjet will be excluded and the dissection willhug the stomach wall.

4) A corresponding area of similar length is cleared of blood vessels onthe greater curvature 212.

5) Endo-Hand 205 is used to lift the stomach up toward the anteriorabdominal wall. This maneuver will open the lesser sac. A rubber tube220 is introduced through the lateral port and then is passed behind thestomach from the greater curvature side and is brought out the smallopening on the lesser curvature side. See FIG. 20. Endo-Hand 205 iswithdrawn.

6) The tube is then brought out through a 12 mm trocar 201 and affixedto the screw-thread protuberance jutting out from the end of theposterior jaw of clip 100. This maneuver is completed outside thepatient. (See detail FIGS. 24 and 25). Specifically, sutures 221 tie towing nut 142 from the end of tube 220 as shown.

7) The rubber tube 220 with clip 100 attached then draws the device intothe trocar 201 by pulling on its other end which is outside the patientexiting form a different trocar (i.e. 203). The clip 100 in the closedposition, is aided in this maneuver by advancing it down the trocarusing a pusher bar.

8) Once clip 100 is inside the abdomen, traction continues on the rubbertube which guides the posterior jaw of the clip into the slot createdbehind the stomach. A grasper through the other port facilitates (202)this maneuver.

9) The smooth surface of the inner jaws of the clip that are lined withGore-tex™ facilitate the positioning of the clip.

10) The rubber tube is disconnected from the protuberance. (See detailFIGS. 25 and 26).

11) The protruding thread screw 140 with its wing nut 142 attached isthen flipped up by means of a grasper to an upright position. (See FIGS.28, 29) It is then guided into the slot 150 on the anterior clasp thatis designed to receive it. The jaws of the clip 100 need to be torquedslightly to carry out this maneuver, but when the upright screw thread140 falls into the off center rounded slot at the end of the slot, thejaws of the clip 100 will be properly aligned.

12-13) The wing nut is turned on the threads a few turns so that thestomach is secured lightly in its jaws. (See FIG. 30).

14) At this point, a special tube M will be inserted down the patient'sesophagus and will pass through the opening in the clip so that its tipis in the larger chamber of the stomach. (See tube 74, FIG. 3) A balloon80 on its end is inflated and the tube pulled back until the opening 102through the clip 100 is sealed. A second balloon 84 more proximal and inthe distal esophagus is now inflated thus sealing off the proximalstomach chamber. A port 90 in the side of the tube between the twoballoons is now injected with saline. The surgeon will observe theproximal stomach fill with fluid and can measure or approximate the sizeand volume of the pouch. Should the pouch be too large or too small thesurgeon can move clip 100 proximally or distally to adjust the size ofthe proximal stomach pouch.

15) A sensor N measuring blood flow attached to a 5 mm rod will be thenintroduced down a trocar. This can either be an ultrasonic device or alaparoscopic adapted instrument that can be attached to the standardblood flow/oxygenation sensing device taped to the fingertip of patientby the anesthesiologist. Such a device, (manufactured by Nellcor Corp.Hayward, Calif.) is a common appliance found in virtually everyoperating room. It reads the patient's pulse and oxygenation saturationusing light to record the degree of blood flow by the redness of thetissues. A sensing device utilizing the same principle attached to theend of a laparoscopic instrument would be placed in contact with theanterior stomach wall. A series of readings could be easily taken alongthe length of exposed in the slots 160 in the anterior jaw of the clip100. This maneuver would determine the state of the blood flow in thecrushed portion of the stomach.

16) Using the sensor device, the wing nut 142 is now graduallytightened. This maneuver closes the jaws of the clip 100 which in turncompresses the anterior and posterior walls of the stomach.

17) As the stomach walls are compressed within the jaws of the clip, thesurgeon observes the sensor and tightens the wing nut until the sensorregisters no flow. Then the surgeon backs off the wing nut 142 untilflow returns. This maneuver ensures that the clip will be tight enoughto prevent leakage across the clip, but not so tight that the walls ofthe stomach are deprived of their blood supply.

18) The mesh fringes 170 extending beyond the anterior jaw's superiorand inferior margins are now smoothed out to lie flat upon the anteriorsurface of the stomach. Staples from a hernia stapler are then used tofurther affix the clip to the stomach by placing them into the Marlex™mesh that extends from the frame of the clip.

19) The instruments are withdrawn and the trocar sites are closed. Thepatient can be fed that night and most likely can be discharged the nextday.

The advantages of clip 100 are present. It will be relativelyinexpensive to produce. Its size and design will allow it to be used ina laparoscopic morbid obesity operation which in turn will bring about asignificant reduction in operative morbidity. In addition, by not usingthe staple technology to define the aperture of the stomach, issues ofloss of the newly defined aperture are negated.

The concern over necrosis of the stomach wall by a compressing externaldevice can be assuaged by the use of blood flow sensors. Ulcer formationshould not be a problem because of the technique of the measurement ofthe blood flow and the tightening of the clip 100. The two surfaces ofthe stomach that are compressed against each other should atrophy overtime from the pressure and the acid producing cells should no longerfunction. The clip will not interfere with the blood or nerve supply tothe stomach. The staples affixing the mesh to the stomach should preventthe clip from migrating. Weight loss should be significant. Should thenecessity arise that the operation be reversed, this can be easilyaccomplished by removing the clip. This too can be accomplishedlaparoscopically.

Clip 100 has a non penetrating feature making it a gastric non invasiveprocedure because the stomach's mucosa is never exposed. Unlike the VBGand the Gastric Bypass, there are no suture lines to disrupt or leak.There are no anastomotic lines to worry about and the clip 100 isrelatively simple.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that certain changes and modificationsmay be practiced within the scope of the appended claims.

What is claimed is:
 1. A method for performing laparoscopic gastroplastyon a patient, said method comprising:percutaneously introducing aplurality of trocars through the patient's abdominal wall; visualizingthe patient's stomach using a laparoscope disposed in one of thetrocars; manipulating the stomach to expose the lesser curvature,anterior, and posterior walls of the stomach to the laparoscope;dissecting the stomach from the mesentery along the lesser and greatercurvatures dividing the stomach along a line into a proximal pouchadjacent the esophagus and a distal region; introducing a banding devicefor encircling the stomach along a dissecting line for defining theproximal pouch, the distal region with an aperture defined between theproximal pouch and the distal region; introducing a nasogastric tubeinto the stomach so that it passes through the aperture; inflating afirst balloon on the nasogastric tube distally of the aperture and asecond balloon in the esophagus, to seal the proximal pouch in thestomach; introducing a measured volume of fluid into the proximal pouchthrough the nasogastric tube until the pouch is filled; repositioningthe banding device and reintroducing fluid until the position of thebanding device provides a preselected fluid volume upon filling; andclosing the banding device over the stomach along a line defined by theaperture in the band at its final position, with a passage between theproximal pouch and distal region of the stomach being defined by theaperture.
 2. A method for performing laparoscopic gastroplasty on apatient according to claim 1 and wherein said introducing of saidbanding device includes:introducing a band having staples thereon with aportion of said band defining said aperture; and, said closing stepincludes: closing said staples on said band to define said aperture withsaid band and fastening the distal ends of said band with said staplesacross said stomach.
 3. A method for performing laparoscopicgastroplasty on a patient according to claim 1 and wherein saidintroduction of said banding device includes:introducing a clip havingopposed portions thereon with said opposed portions each definingportions of said aperture; and said closing step includes: closing saidclip about said stomach to define a proximal pouch to said stomach.
 4. Amethod for performing laparoscopic gastroplasty on a patient accordingto claim 3 and including the steps of:fastening mesh to said bandingdevice, and, stapling said mesh to at least one wall of said stomach toinsure against migration of said banding device.
 5. A method forperforming laparoscopic gastroplasty on a patient according to claim 1and including the further step of:examining the arterial blood flow ofsaid stomach during closing of said banding device.
 6. A method forperforming laparoscopic gastroplasty on a patient according to claim 1and wherein said introducing step includes:laparoscopically passing amember from the anterior of said patient around the posterior of saidstomach and threading said member exterior of said patient; attaching abanding device to said exteriorly threaded member; drawing said bandingdevice interiorly of said patient utilizing said member to lodge aportion of said device posterior of said stomach; and, fastening saidbanding device over said stomach.